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Trial registered on ANZCTR


Registration number
ACTRN12616001479493
Ethics application status
Approved
Date submitted
23/09/2016
Date registered
24/10/2016
Date last updated
24/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dynamic response to fluid challenge administration in operating room: a pilot trial.
Scientific title
Dynamic response to fluid challenge administration in operating room: a pilot trial.
Secondary ID [1] 290158 0
Nihil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Patients 300382 0
Hemodynamic instability 300383 0
Hypotension 300528 0
Condition category
Condition code
Anaesthesiology 300246 300246 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fluid challenge consisting in 500 ml of intravenous crystalloids (both saline 0,9% or Ringer Acetate or Lactate were allowed), administered in 10 minutes.
The Fluid challenge is administered by the attending physician to correct hemodynamic instability during the surgical procedure (see also eligibility).
All the patients received hemodynamic monitoring with the MostCare system which provides all the hemodynamic variables evaluated in the study before and after fluid challenge administration (cardiac output, stroke volume, arterial elastance, cardiac cycle efficiency)
All patients will receive an echocardiographic assessment before and after the FC including, tissue doppler waveforms (both right and left ventricle), mitral pattern assessment (includine E/e'; E/A waves analysis), Velocity time integral of aortic flow pattern (VTI) and VTI variations
Intervention code [1] 295976 0
Treatment: Other
Comparator / control treatment
The pulse pressure variation, a dynamic index of fluid responsiveness, has been considered as the gold standard. Pulse pressure variation was recorded during in operating room during the surgical procedure. Off line evaluation of PPV before and after the fluid challenge was the used as control treatment
Control group
Active

Outcomes
Primary outcome [1] 299720 0
Aim of the present study is assessing whether a model including pulse pressure variation, cardiac cycle efficiency, arterial elastane and dicrotic pressure assessed by MostCare system, changes during a fluid challenge infusion anticipate its outcome, compared to the standard assessment.
Timepoint [1] 299720 0
single time point: the end of fluid challenge (duration 10 minutes)
Secondary outcome [1] 327945 0
The assessment of the area under the curve (AUC) of the predefined variables included in the model (pulse pressure variation, cardiac cycle efficiency, arterial elastane and dicrotic pressure)
Timepoint [1] 327945 0
single time point: the end of fluid challenge (duration 10 minutes)

Eligibility
Key inclusion criteria
1) to have > or = 18 years
2) to be scheduled for elective open abdominal surgery under general anesthesia with mechanical ventilation with a volume controlled mode (with a tidal volume (VT) < 8 ml/kg),
3) to require an invasive blood pressure monitoring.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) the American Society of Anesthesiologists' physical status classification (ASA) equal to 4,
2) presence of a previous history of arrhythmia, or left ventricular ejection fraction < 30%, or right ventricular dysfunction (assessed by a < 0.16 m/s of systolic peak velocity of tricuspid annular motion), or a moderate to severe valvular heart disease , or intra-cardiac shunt, 3) chronic medication with beta-blockers.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Normal distribution was evaluated by means of the Kolmogorov-Smirnov test. All the considered variables were averaged over one minute and average values were used for all comparisons. ROC curves (95% confidence interval, [CI]) were constructed for percent changes of PPV between baseline mean value vs. the response to the FC.
The variations of CCE and MAP- Pdic, Ea and SAP – Pdic were compared using analysis of variance (ANOVA); for nonparametric data the Friedman test followed by Dunn multiple comparisons and for parametric data ANOVA with Bonferroni post hoc tests adjusting for multiple comparisons were used. The Greenhouse-Geisser correction was used when sphericity could not be assumed.
We performed bivariate analyses using the t-test for quantitative variables and the chi-square test (or Fisher’s exact test, if indicated) for qualitative variables and constructed a bivariate logistic regression model. The model include, baseline PPV, the variation of CCE, Ea, MAP- Pdic, Ea and SAP – Pdic between baseline and the first minute measuring a variation statistically significant for DELTA_CCE, DELTA_MAP- Pdic, DELTA_Ea and DELTA_SAP – Pdic. A Hosmer & Lemeshow test was calculated to evaluate the model fit.
Statistical analyses were conducted using SPPS version 30.0 (SPSS, Inc., Chicago, IL). For all comparisons, we considered significant p values < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8259 0
Italy
State/province [1] 8259 0
Novara, Florence

Funding & Sponsors
Funding source category [1] 294576 0
Hospital
Name [1] 294576 0
AOU Maggiore della Carita'
Address [1] 294576 0
Corso Mazzini, 18
28100 Novara (NO)
Country [1] 294576 0
Italy
Primary sponsor type
Individual
Name
Antonio Messina
Address
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Intensive care unit
Country
Italy
Secondary sponsor category [1] 293443 0
None
Name [1] 293443 0
nihil
Address [1] 293443 0
nihil
Country [1] 293443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296010 0
Comitato etico Interaziendale AOU Maggiore della Carita'
Ethics committee address [1] 296010 0
Corso Mazzini, 18
28100 Novara (NO)
Ethics committee country [1] 296010 0
Italy
Date submitted for ethics approval [1] 296010 0
23/08/2014
Approval date [1] 296010 0
26/09/2014
Ethics approval number [1] 296010 0
Protocol 838/CE, CE 118/14

Summary
Brief summary
Background: Assessing preload dependence by means of static and dynamic indexes of fluid responsiveness is limited to a minority of critically ill and surgical patients. The lack in the sensitivity and specificity of these indexes in revealing fluid responsiveness before fluid challenge (FC) administration increases the risk of fluid overloading. Since, in responders and non-responders, the FC causes different hemodynamic effects in cardiac function and peripheral tone the outcome could be predicted before the entire infusion by dynamically assessing these variables.
Methods: 50 patients scheduled for elective abdominal surgery. The FC was administered to improve an episode of hemodynamic instability, and consisted in 500 ml of crystalloids in 10 minutes. A bivariate logistic regression mode was constructed to predict the outcome of the FC including baseline pulse pressure variation (PPV), and four different cardiovascular indexes provided by the MostCare.
Design: prospective multicentric study
Trial website
Trial related presentations / publications
Preliminary data of the present trial have been presented to the 29 ESICM congress 2016 (1-5 October, Milan- Italy): "EARLY VARIATIONS OF PULSE PRESSURE VARIATION, CARDIAC CYCLE EFFICIENCY AND DICROTIC PRESSURE TO PREDICT FLUID CHALLENGE SUCCESS
Abstract Presenter: Antonio Messina, MD, AOU Maggiore della Carita' (Novara, Italy). Poster Corner presentation; 3 October.
Public notes

Contacts
Principal investigator
Name 69066 0
Dr Antonio Messina
Address 69066 0
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Country 69066 0
Italy
Phone 69066 0
+3903213733380
Fax 69066 0
Email 69066 0
mess81rc@gmail.com
Contact person for public queries
Name 69067 0
Dr Antonio Messina
Address 69067 0
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Country 69067 0
Italy
Phone 69067 0
+3903213733380
Fax 69067 0
Email 69067 0
mess81rc@gmail.com
Contact person for scientific queries
Name 69068 0
Dr antonio messina
Address 69068 0
AOU Maggiore della Carita'
Corso Mazzini, 18
28100 Novara (NO)
Country 69068 0
Italy
Phone 69068 0
+3903213733380
Fax 69068 0
Email 69068 0
mess81rc@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary